Syngene International Ltd
Designation : Executive
Function : Human Pharmacology Unit
Functional Area : QC
Job Role Summary : Perform Quality Control checks of HPU facility systems, CRF, TMF, other study documents
Job Profile :
- Perform QC checks of draft CRF and other study related documents.
- Monitor the pre-check-in, check-in, pre-dose, dosing, post-dose study activities as per protocol, SOP/IOPs and regulatory guidelines.
- Perform Periodic checks for essential documents filed in TMF or study related files at different stages such as before study activity starts, during the study and after the completion of the study.
- QC check for source documents transcribed data with CRF entries and other study related documentation.
- Provide Line clearance, Line Opening and Line Cleaning to the Lab technician for the generation of Labels pertaining to Vacutainers and RIA vials.
- Provide Line clearance, Line Opening and Line Clearance for dispensing labels in pharmacy.
- Generate Quality Control Report for study activities and/or supporting documents.
- Verify the response to sponsor/QA observation noted during their data review or visit to facility in coordination with HPU staff and Investigators.
- Review of CSR and appendices.
- Archival of all study files.
- Verification of oceasoft and archival as per the sop SOP-GCP-HPU-0065
- Review of qualification documents as and when required.
- Prepare and present trend analysis report of observations to Head HPU and reporting managers once in a month or as and when needed as per Head HPU instructions.
- Issue True copy of verified calibration / validation reports for display in their respective areas
Job Requirements :
Human Pharmacology QC, QA experience
Type of Experience : Human Pharmacology Unit QC, QA experience
Academic Qualifications :
Post graduates in Pharmacy, Life Sciences
